ML20010B846
| ML20010B846 | |
| Person / Time | |
|---|---|
| Issue date: | 08/07/1981 |
| From: | Wiedeman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20010B845 | List: |
| References | |
| NUDOCS 8108180367 | |
| Download: ML20010B846 (1) | |
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A Appendix A NOTICE OF VIOLATION Proctor Community Hospital License No. 12-05640-01 As a result of the inspection conducted on July 30, 1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violation was identified:
10 CFR 35.14(b)(6) requires that for Groups I, II and III any licensee using byproduct material for clinical procedures other than those specified in the product labeling (package insert) shall comply with the labeling regarding:
(i)
Chemical and physical form; (ii)
Route of administration; and, (iii)
Dosage range.
Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspectors review of records that this condition is not being met.
Specifically, during the last fifteen months, eight intra-urethra catheterizations of the urinary bladder (Cystograms) were performed. This procedure is not described in the manufacturer's package insert as an authorized route of administration.
This is a Severity Level V violation (Supplement VII).
Pursuant to the provisions of 10 CFR 2.201, you are required to submit to this office within thirty days of the date of this Notice a written state-ment or explanation in reply, including for each item of noncompliance:
(1) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full compliance will be achieved. Under the authority of Section 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitted under oa.h or affirmation. Consideration may be given to extending your response time for good cause shown.
/-7W g_
Dated D. G. Wiedeman, Acting Chief Materials Radiation Protection Section 1 8108100367 810807 "
NMS LIC30 12-05640-01 PDR
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